Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:02 PM
Study NCT ID:
NCT00854828
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2009-03-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bridwellk@wustl.edu', 'phone': '314-747-2655', 'title': 'Keith H. Bridwell, MD', 'organization': 'Washington University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored/assessed in *each participant* from enrollment through study completion (end of funding), an average of 3.6 years. Specific amount of time for each individual is dependent upon when he/she entered the study and if/when they withdrew from the study.', 'description': 'Serious Adverse Events (SAE) were any events that resulted in:\n\nDeath Hospitalization (new or prolonged) - Exception was hospitalization for index spinal deformity correction surgery.\n\nNew disability (significant or permanent) Life threatening Unexpected but Reasonably Related to the Intervention', 'eventGroups': [{'id': 'EG000', 'title': "Surgical Intervention-As Treated AE's Occurring While Patient Was in Surgical Arm", 'description': "Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis. AE's are reported in the treatment arm (surgical or non-operative) patient was in at time of AE. A total of 171 patients had surgical intervention. This number includes non operative patients who crossed over to surgical intervention. Some patients spent time and had AEs in both treatment arms.", 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 128, 'seriousNumAtRisk': 171, 'deathsNumAffected': 3, 'seriousNumAffected': 85}, {'id': 'EG001', 'title': "Non-Operative Intervention-As Treated AE's Occurring While Patient Was on Non Operative Arm", 'description': "Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. AE's are reported in the treatment arm (surgical or non-operative) patient was in at time of AE. A total of 150 had non operative interventions.", 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 70, 'seriousNumAtRisk': 150, 'deathsNumAffected': 2, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Musculoskeletal Event (excluding spine related symptoms)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 86, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 56, 'numAffected': 43}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medication Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocrine System Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Circulatory Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non SEER cancer', 'notes': 'Basal and squamous cell skin cancers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infectious Event (non spine)', 'notes': 'Ear, sinus, lyme disease, infected bites, herpes, etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychosocial Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reproductive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Misc events', 'notes': 'Shingles, Low B12, tinnitus, syncope, restless leg syndrome, cat bite, neuropathies d/t chemo, etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrospinal fluid leak (intra-op)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Excessive blood loss/Intraop Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ineffective fixation/Posterior element fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal implant failure (no revision)', 'notes': 'Spinal implant failure (rod fracture, hook/screw pull out, etc) that did not require revision surgery prior to end of funding. Those failures that were revised were considered SAE and reported under SAEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Proximal junctional kyphosis/breakdown (No revision required)', 'notes': 'Proximal breakdown that required revision surgery during funding is considered an SAE and reported as SAE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Spine wound problems (Not requiring admission)', 'notes': 'Superficial and deep wound infections that did not require a hospitalization. If hospitalization was required, it was considered an SAE and is reported under SAEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Surveillance, Epidemiology and End Results (SEER) Cancers', 'notes': 'All Surveillance, Epidemiology and End Results (SEER) cancers occurring during the study were considered an SAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Events', 'notes': 'Cardiac events that met NIAMS SAE criteria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Events', 'notes': 'GI events that met NIAMS SAE definitions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary Event', 'notes': 'Genitourinary events meeting NIAMS SAE reporting criteria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Event', 'notes': 'Pulmonary related events meeting NIAMS SAE reporting guidelines', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgeries Unrelated to Adult Symptomatic Lumbar Scoliosis', 'notes': 'Surgical events NOT related to adult scoliosis resulting new hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 45, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Miscellaneous SAE', 'notes': "Misc events meeting NIAMS SAE criteria. Examples: Accidental injury, Dehydration, Altered metal status, Panic Attack, C spine stenosis, septic arthritis, anaphylactic shock, Addison's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adult Lumbar Scoliosis Events', 'notes': 'Adult Scoliosis events meeting NIAMS SAE criteria. Examples: Lumbar stenosis, revision scoliosis spine surgeries)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 66, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Circulatory Disorders', 'notes': 'Circulatory Events meeting NIAMS SAE criteria such as transient ischemic attack, cerebrovascular accident, Deep Vein Thrombosis, Pulmonary Embolism)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Surgical Intervention', 'description': 'Patients consenting to randomization and assigned to Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis'}, {'id': 'OG001', 'title': 'Randomized Non-Operative Intervention', 'description': 'Patients consenting to randomization and assigned to Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.8'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-year', 'description': 'Change was calculated as the SRS QOL Subscore value at 2-year minus the value at Baseline for Randomized Cohort (Intent-to-Treat analysis).\n\nSRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in analysis.'}, {'type': 'PRIMARY', 'title': 'Scoliosis Research Society Quality of Life (SRS QOL) Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Cohort Surgical Intervention', 'description': 'Patients consenting to Observational cohort participation, electively choosing Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis'}, {'id': 'OG001', 'title': 'Observational Cohort Non-Operative Intervention', 'description': 'Patients consenting to Observational cohort participation, electively choosing Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '0.8'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-year', 'description': 'Change was calculated as the SRS QOL Subscore value at 2-year as-treated follow-up minus the value at Baseline in the Observational cohort.\n\nSRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Observational participants were included. Crossover participants provided data in both treatment arms.'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index (ODI) - Randomized Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Cohort Surgical Intervention', 'description': 'Patients consenting to randomization and assigned to Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis'}, {'id': 'OG001', 'title': 'Randomized Cohort Non-Operative Intervention', 'description': 'Patients consenting to randomization and assigned to Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '-7'}, {'value': '-9', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '-4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-year', 'description': 'Change was calculated as the ODI score at 2-year minus the value at Baseline in Randomized Cohort (intent-to-treat analysis).\n\nODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included.'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Cohort Surgical Intervention', 'description': 'Patients consenting to Observational cohort participation, electively choosing Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis'}, {'id': 'OG001', 'title': 'Observational Cohort Non-Operative Intervention', 'description': 'Patients consenting to Observational cohort participation, electively choosing Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15', 'groupId': 'OG000', 'lowerLimit': '-18', 'upperLimit': '-13'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2-year', 'description': 'Change was calculated as the ODI score at 2-year as treated follow-up minus the value at baseline.\n\nODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All observational participants were included. Crossover participants provided data in both arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Randomized Cohort/Operative Intervention', 'description': 'Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis.'}, {'id': 'FG001', 'title': 'Randomized Cohort/Non-Operative Intervention', 'description': 'Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.'}, {'id': 'FG002', 'title': 'Observational Cohort/Operative Intervention', 'description': 'Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis.'}, {'id': 'FG003', 'title': 'Observational Cohort/Non-Operative Intervention', 'description': 'Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Baseline enrollment data collected and completed intervention.', 'achievements': [{'comment': '6 patients crossed over to non-operative intervention.', 'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '112'}, {'groupId': 'FG003', 'numSubjects': '111'}]}, {'type': '3 Months Post Intervention', 'achievements': [{'comment': '6 missed visits', 'groupId': 'FG000', 'numSubjects': '24'}, {'comment': '1 missed visit', 'groupId': 'FG001', 'numSubjects': '32'}, {'comment': '112 (100%) of patients underwent operative treatment.', 'groupId': 'FG002', 'numSubjects': '112'}, {'comment': '2 missed visits. 3 withdrew.', 'groupId': 'FG003', 'numSubjects': '106'}]}, {'type': '12 Months Post Intervention', 'achievements': [{'comment': '2 missed visits.\n\n1 withdrew.\n\n1 deceased.', 'groupId': 'FG000', 'numSubjects': '26'}, {'comment': '1 withdrew. 15 (45%) crossed over to operative treatment.', 'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '112'}, {'comment': '4 missed visits. 6 withdrew. 6 (5%) crossed over to operative treatment.', 'groupId': 'FG003', 'numSubjects': '101'}]}, {'type': '24 Months Post Intervention', 'achievements': [{'comment': '1 missed visit.\n\n1 withdrew.\n\n1 deceased. 24 patients (80%) underwent surgery.', 'groupId': 'FG000', 'numSubjects': '27'}, {'comment': '1 missed visit.\n\n1 withdrew. 21 (64%) crossed over to operative treatment.', 'groupId': 'FG001', 'numSubjects': '31'}, {'comment': '8 missed visits.', 'groupId': 'FG002', 'numSubjects': '104'}, {'comment': '8 missed visits. 9 withdrew. 14 (13%) crossed over to operative treatment.', 'groupId': 'FG003', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Missed 24mo visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized Cohort/Operative Intervention', 'description': 'Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis'}, {'id': 'BG001', 'title': 'Randomized Cohort/Non-Operative Intervention', 'description': 'Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.'}, {'id': 'BG002', 'title': 'Observational Cohort/Operative Intervention', 'description': 'Operative intervention: Operative intervention as appropriate for adults with symptomatic lumbar scoliosis'}, {'id': 'BG003', 'title': 'Observational Cohort/Non-Operative Intervention', 'description': 'Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '66'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '57', 'upperLimit': '69'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '64'}, {'value': '61', 'groupId': 'BG003', 'lowerLimit': '54', 'upperLimit': '69'}, {'value': '61', 'groupId': 'BG004', 'lowerLimit': '54', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '258', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '270', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}, {'value': '267', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '267', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Scoliosis Research Society (SRS) Subscore', 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'BG000', 'lowerLimit': '2.7', 'upperLimit': '3.5'}, {'value': '2.9', 'groupId': 'BG001', 'lowerLimit': '2.7', 'upperLimit': '3.5'}, {'value': '3.1', 'groupId': 'BG002', 'lowerLimit': '2.7', 'upperLimit': '3.5'}, {'value': '3.4', 'groupId': 'BG003', 'lowerLimit': '3.0', 'upperLimit': '3.7'}, {'value': '3.2', 'groupId': 'BG004', 'lowerLimit': '2.8', 'upperLimit': '3.6'}]}]}], 'paramType': 'MEDIAN', 'description': 'Scores range from 1 (worst score) to 5 (best score).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'SRS Pain Domain', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'BG000', 'lowerLimit': '2.6', 'upperLimit': '3.4'}, {'value': '2.8', 'groupId': 'BG001', 'lowerLimit': '2.2', 'upperLimit': '3.2'}, {'value': '2.8', 'groupId': 'BG002', 'lowerLimit': '2.2', 'upperLimit': '3.3'}, {'value': '3.0', 'groupId': 'BG003', 'lowerLimit': '2.6', 'upperLimit': '3.6'}, {'value': '2.9', 'groupId': 'BG004', 'lowerLimit': '2.4', 'upperLimit': '3.4'}]}]}], 'paramType': 'MEDIAN', 'description': 'Scores range from 1 (worst score) to 5 (best score).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'SRS Function Domain', 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'BG000', 'lowerLimit': '2.8', 'upperLimit': '3.8'}, {'value': '3.0', 'groupId': 'BG001', 'lowerLimit': '2.8', 'upperLimit': '3.6'}, {'value': '3.2', 'groupId': 'BG002', 'lowerLimit': '2.6', 'upperLimit': '3.8'}, {'value': '3.4', 'groupId': 'BG003', 'lowerLimit': '3.0', 'upperLimit': '3.8'}, {'value': '3.4', 'groupId': 'BG004', 'lowerLimit': '2.8', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'Scores range from 1 (worst score) to 5 (best score).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'SRS Self-image Domain', 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'BG000', 'lowerLimit': '2.3', 'upperLimit': '3.3'}, {'value': '2.8', 'groupId': 'BG001', 'lowerLimit': '2.5', 'upperLimit': '3.2'}, {'value': '2.8', 'groupId': 'BG002', 'lowerLimit': '2.2', 'upperLimit': '3.3'}, {'value': '3.0', 'groupId': 'BG003', 'lowerLimit': '2.7', 'upperLimit': '3.5'}, {'value': '2.8', 'groupId': 'BG004', 'lowerLimit': '2.5', 'upperLimit': '3.3'}]}]}], 'paramType': 'MEDIAN', 'description': 'Scores range from 1 (worst score) to 5 (best score).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'SRS Mental Health Domain', 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'BG000', 'lowerLimit': '3.0', 'upperLimit': '4.4'}, {'value': '4.0', 'groupId': 'BG001', 'lowerLimit': '3.2', 'upperLimit': '4.0'}, {'value': '3.8', 'groupId': 'BG002', 'lowerLimit': '3.2', 'upperLimit': '4.2'}, {'value': '3.8', 'groupId': 'BG003', 'lowerLimit': '3.2', 'upperLimit': '4.4'}, {'value': '3.8', 'groupId': 'BG004', 'lowerLimit': '3.2', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEDIAN', 'description': 'Scores range from 1 (worst score) to 5 (best score).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Oswestry Disability Index (ODI)', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '46'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '54'}, {'value': '37', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '48'}, {'value': '32', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '40'}, {'value': '34', 'groupId': 'BG004', 'lowerLimit': '24', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'description': 'Scores range from 100 (worst score) to 0 (best score).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Numeric Rating Scale (NRS) Back Pain', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '5', 'groupId': 'BG003', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG004', 'lowerLimit': '5', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'description': 'Scores range from 10 (worst score) to 0 (best score).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Numeric Rating Scale (NRS) Leg Pain', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '3', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG004', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'description': 'Scores range from 10 (worst score) to 0 (best score).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Short form-12 (SF-12) Mental Component Score', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '61'}, {'value': '51', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '57'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '59'}, {'value': '51', 'groupId': 'BG003', 'lowerLimit': '43', 'upperLimit': '59'}, {'value': '51', 'groupId': 'BG004', 'lowerLimit': '42', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'description': "Percentiles range from 0 to 100 with 'norm' being 50.", 'unitOfMeasure': 'Percentile', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'SF-12 Physical Component Score', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '42'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '40'}, {'value': '34', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '40'}, {'value': '37', 'groupId': 'BG003', 'lowerLimit': '29', 'upperLimit': '44'}, {'value': '35', 'groupId': 'BG004', 'lowerLimit': '27', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'description': "Percentiles range from 0 to 100 with 'norm' being 50.", 'unitOfMeasure': 'Percentile', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lumbar Cobb Angle', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '62'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '37', 'upperLimit': '63'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '69'}, {'value': '48', 'groupId': 'BG003', 'lowerLimit': '39', 'upperLimit': '57'}, {'value': '51', 'groupId': 'BG004', 'lowerLimit': '42', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'description': 'Lumbar Cobb angle is the measurement of the scoliosis (curve in the coronal plane) measured in degrees. Normal is 0.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lumbar Lordosis (T12-Sacrum)', 'classes': [{'categories': [{'measurements': [{'value': '-32', 'groupId': 'BG000', 'lowerLimit': '-56', 'upperLimit': '-22'}, {'value': '-38', 'groupId': 'BG001', 'lowerLimit': '-47', 'upperLimit': '-20'}, {'value': '-38', 'groupId': 'BG002', 'lowerLimit': '-49', 'upperLimit': '-28'}, {'value': '-45', 'groupId': 'BG003', 'lowerLimit': '-55', 'upperLimit': '-32'}, {'value': '-40', 'groupId': 'BG004', 'lowerLimit': '-53', 'upperLimit': '-27'}]}]}], 'paramType': 'MEDIAN', 'description': "Lumbar lordosis is the sagittal plane measurement of T12 to S1 in degrees. Mean for normal adults is 64 degrees +/- 10 degrees based on 'An analysis of sagittal spinal alignment in 100 asymptomatic middle and older aged volunteers' published in SPINE, Vol 20, number 12, pp 1351-1358 in 1995.", 'unitOfMeasure': 'Degrees', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sagittal balance (C7 to Sacrum plumb)', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '57'}, {'value': '34', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '70'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '56'}, {'value': '33', 'groupId': 'BG003', 'lowerLimit': '16', 'upperLimit': '55'}, {'value': '30', 'groupId': 'BG004', 'lowerLimit': '15', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'description': 'Measured in mm from mid body C7 to front of plumb in sagittal plane. Negative value indicates C7 plumb falls BEHIND sacrum. Ideal would be 0mm.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Coronal balance', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '30'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '14', 'upperLimit': '38'}, {'value': '19', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '35'}, {'value': '14', 'groupId': 'BG003', 'lowerLimit': '8', 'upperLimit': '26'}, {'value': '18', 'groupId': 'BG004', 'lowerLimit': '9', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'description': 'Measure (in mm) mid body C7 to mid Sacrum plumb in coronal plane, Values reported in absolute values. Ideal = 0mm.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Pelvic Incidence-Lumbar Lordosis Mismatch', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '32'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '34'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '30'}, {'value': '13', 'groupId': 'BG003', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '16', 'groupId': 'BG004', 'lowerLimit': '3', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'description': 'Mathematical difference between pelvic incidence and lumbar lordosis radiographic measurements in degrees. Differences \\> 10 degrees correlates with worse patient reported outcomes.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Education', 'classes': [{'title': 'Less than high school', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'High school diploma or GED', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}]}, {'title': "Technical or associate's degree", 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}, {'title': "Bachelor's degree", 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}, {'title': 'Graduate degree', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Income per yer', 'classes': [{'title': '<$20,000', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': '$20,000-39,999', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}, {'title': '$40,000-74,999', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}, {'title': '$75,000+', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}]}, {'title': 'Did not report', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking history', 'classes': [{'title': 'Current smoker', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Former smoker', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '182', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '31'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '30'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '29'}, {'value': '25', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '30'}, {'value': '26', 'groupId': 'BG004', 'lowerLimit': '23', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'description': 'Normal adult BMI is 18.5 to 24.9', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Osteopenia/Osteoporosis', 'classes': [{'title': 'None/Does not apply', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}]}, {'title': 't-score -1 to -1.5', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': 't-score -1.6 to -2.4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': 't-score -2.5 or worse (or vertebral compression fx', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}]}, {'title': 'Yes, controlled with diet/exercise', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Yes, controlled w/medication', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}]}]}, {'title': 'Yes, poorly controlled w/medication', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}]}, {'title': 'Yes, controlled with diet', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Yes, controlled with oral hypoglycemics', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Yes, insulin dependent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Depression/Anxiety/Psychiatric Disorder', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of back symptoms', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '80'}, {'value': '96', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '240'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '60'}, {'value': '24', 'groupId': 'BG003', 'lowerLimit': '2', 'upperLimit': '120'}, {'value': '24', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '102'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Duration of leg symptoms', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '48'}, {'value': '0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '0', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'description': 'Length of time patient reported having Leg symptoms at time of enrollment. If no leg symptoms, patient reported 0 months.', 'unitOfMeasure': 'Months', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Symptomatic adult lumbar scoliosis patients (ages 40-80, lumbar Cobb measurement \\>30° and Oswestry Disability Index (ODI) \\>20 or Scoliosis Research Society-22 \\<4.0) with no prior history of scoliosis surgery from 9 North American centers were enrolled in randomized or observational cohorts to evaluate surgery versus nonoperative treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-01-23', 'size': 930607, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-16T13:47', 'hasProtocol': True}, {'date': '2015-01-23', 'size': 630792, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-16T13:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There were 2 cohorts: Randomized and Observational, each with an operative and non-operative arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2009-03-02', 'resultsFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2009-03-02', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-10', 'studyFirstPostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scoliosis Research Society Quality of Life Questionnaire (SRS QOL) Subscore', 'timeFrame': 'Baseline, 2-year', 'description': 'Change was calculated as the SRS QOL Subscore value at 2-year minus the value at Baseline for Randomized Cohort (Intent-to-Treat analysis).\n\nSRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.'}, {'measure': 'Scoliosis Research Society Quality of Life (SRS QOL) Subscore', 'timeFrame': 'Baseline, 2-year', 'description': 'Change was calculated as the SRS QOL Subscore value at 2-year as-treated follow-up minus the value at Baseline in the Observational cohort.\n\nSRS QOL Subscore value range is 1 to 5, where 5 is the best score and 1 is the worst score possible.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI) - Randomized Cohort', 'timeFrame': 'Baseline, 2-year', 'description': 'Change was calculated as the ODI score at 2-year minus the value at Baseline in Randomized Cohort (intent-to-treat analysis).\n\nODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Baseline, 2-year', 'description': 'Change was calculated as the ODI score at 2-year as treated follow-up minus the value at baseline.\n\nODI score range is 0 to 100, where 0 is the best score and 100 is the worst score possible.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Symptomatic 40-80 y/o w/lumbar Cobb of 30 degrees', 'All Participants must be reasonable surgical candidate at enrollment'], 'conditions': ['Scoliosis']}, 'referencesModule': {'references': [{'pmid': '40172880', 'type': 'DERIVED', 'citation': 'Smith JS, Kelly MP, Yanik EL, Baldus CR, Pham V, Ben-Israel D, Lurie JD, Edwards C, Glassman SD, Lenke LG, Buchowski JM, Carreon LY, Crawford CH 3rd, Lewis SJ, Koski T, Lafage V, Gupta MC, Kim HJ, Ames CP, Bess S, Schwab FJ, Shaffrey CI, Bridwell KH. Operative vs Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis at 8-Year Follow-Up: A Nonrandomized Clinical Trial. JAMA Surg. 2025 Jun 1;160(6):634-644. doi: 10.1001/jamasurg.2025.0496.'}, {'pmid': '35428916', 'type': 'DERIVED', 'citation': 'Dial BL, Hills JM, Smith JS, Sardi JP, Lazaro B, Shaffrey CI, Bess S, Schwab FJ, Lafage V, Lafage R, Kelly MP, Bridwell KH. The impact of lumbar alignment targets on mechanical complications after adult lumbar scoliosis surgery. Eur Spine J. 2022 Jun;31(6):1573-1582. doi: 10.1007/s00586-022-07200-3. Epub 2022 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter study evaluating the effectiveness of nonoperative and operative treatments. The investigators wish to identify important clinical and radiographic determinants of outcomes in the management of adults with symptomatic lumbar scoliosis (ASLS).\n\nNote: Enrollment was complete July 2014. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) funding ended 2/28/17. We continue to follow enrolled subjects while we seek additional funding to follow all subjects through 8 years.', 'detailedDescription': 'Specific Aim #1: Compare the outcomes of surgery and nonoperative treatment in patients aged 40 to 80 with ASLS defined as a lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry (ODI) score of 20 or more; or Scoliosis Research Society Quality of Life instrument (SRS-QOL) score of 4.0 or less, in the domains of pain, function and/or appearance.\n\nSpecific Aim #2: Evaluate the impact of patient factors (age, gender, socioeconomic status, education) and comorbidities \\[mental health, body mass index (BMI) and bone mineral density (BMD)\\] on adverse events and treatment outcomes for both the nonoperative and operative arms. Incorporate these variables into a prediction model to help identify those patients most likely to benefit from either a surgical or nonoperative approach'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged 40 to 80 years with\n* ASLS defined as lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry Disability Index (ODI) score ≥ 20 or SRS-QOL score ≤ 4.0 in the domains of pain, function and/or appearance.\n* If assigned to surgical intervention (by randomization or patient preference), the intervention plan would include, at a minimum, the Cobb levels of the Thoracolumbar/lumbar spine.\n\nExclusion Criteria:\n\n* Substantial cardiac, pulmonary, renal or metabolic disease that, in the judgment of the surgical team, would preclude performing an operative procedure without undue risk of morbidity and mortality\n* Concomitant high-grade spondylolisthesis (Grade 3)\n* Prior thoracic or multiple level lumbar laminectomy or decompression \\[single or two level lumbar decompression (e.g., herniated disc) will not be an exclusion\\]\n* Prior thoracic or lumbar fusion\n* Osteoporosis evidence by a dual-energy x-ray absorptiometry (DEXA) T-score \\<-3.0 at hip or lumbar spine for patients considered to be at risk (post menopausal females, males \\> 60 years of age, steroid dependent rheumatoid arthritics, status post organ transplantation, etc.). Patients may be randomized prior to obtaining DEXA results. Non Surgical patients may initiate non surgical treatments prior to completion of DEXA (if required) as non surgical treatments will not affect DEXA results but DEXA must be completed and results entered within 3 months of enrollment. Surgical patient must have DEXA prior to surgical intervention.\n* Neuromuscular scoliosis (e.g., spinal muscular atrophy, cerebral palsy, Parkinson's Disease, post-polio syndrome, Charcot Marie Tooth disease)\n* Congenital scoliosis in the lumbar spine. Congenital anomalies of the cervical or thoracic spine are acceptable.\n* Spine tumor, infection or connective tissue disorder\n* Cognitively impaired or unable/unwilling to comply with follow-up\n* Pregnancy or planning on conceiving during time of study involvement\n* Ankylosing Spondylitis\n* Past history of vertebroplasty or kyphoplasty of the thoracic or lumbar spine"}, 'identificationModule': {'nctId': 'NCT00854828', 'acronym': 'ASLS', 'briefTitle': 'A Multicenter Prospective Study of Quality of Life in Adult Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Multicenter Prospective Study of Quality of Life in Adult Scoliosis', 'orgStudyIdInfo': {'id': 'R01AR055176-01A2', 'link': 'https://reporter.nih.gov/quickSearch/R01AR055176-01A2', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01AR055176', 'link': 'https://reporter.nih.gov/quickSearch/R01AR055176', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical Intervention', 'interventionNames': ['Procedure: Surgical intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Operative Intervention', 'interventionNames': ['Other: Non-operative intervention']}], 'interventions': [{'name': 'Surgical intervention', 'type': 'PROCEDURE', 'description': 'Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis', 'armGroupLabels': ['Surgical Intervention']}, {'name': 'Non-operative intervention', 'type': 'OTHER', 'description': 'Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.', 'armGroupLabels': ['Non-Operative Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21212', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Spine Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'HrJ 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Hopital du Sacre'", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Keith H Bridwell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Jon Lurie, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}, {'name': 'Christopher Shaffrey, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}, {'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'New York University', 'class': 'OTHER'}, {'name': 'University of Virginia', 'class': 'OTHER'}, {'name': 'University of Louisville', 'class': 'OTHER'}, {'name': 'Maryland Spine Center', 'class': 'OTHER'}, {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, {'name': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal", 'class': 'OTHER'}, {'name': 'Dartmouth College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}